MODIFICATION TO AXXESS SPINAL CORD STIMULATION LEAD

K030674 · Advanced Neuromodulation Systems · GZB · Mar 28, 2003 · Neurology

Device Facts

• Record ID: K030674
• Device Name: MODIFICATION TO AXXESS SPINAL CORD STIMULATION LEAD
• Applicant: Advanced Neuromodulation Systems
• Product Code: GZB · Neurology
• Decision Date: Mar 28, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.5880
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The AXXESS™ Lead is designed to be utilized as the lead component of a spinal cord stimulation system and is used to aid in the management of chronic pain of the trunk and/or extremities. The AXXESS™ lead system is designed to be used with the following devices: - Medtronic® Mattrix® Model 3272 RF system receiver and compatible transmitter, or . - Medtronic® X-TREL® Model 3470 RF system receiver and compatible transmitter ● using the Medtronic® Model 7495 Quadripolar extension , and - Medtronic® Model 3550-05 Percutaneous Extension with the Medtronic® Model 3550-. 03 Screener cable, and - The Medtronic® Model 3628 DualScreen™ Screener using Axxess Screener Cable or ● - The ANS TS-8 or MNT90T/TR-16 Test Stimulator using Axxess Screener Cable.

Device Story

Axxess Spinal Cord Stimulation Lead (Model 8000 Series) functions as lead component for spinal cord stimulation systems. Device delivers electrical stimulation to spinal cord to manage chronic pain of trunk/extremities. Designed for compatibility with specific Medtronic RF receivers/transmitters (Mattrix Model 3272, X-TREL Model 3470) and ANS/Medtronic test stimulators/screeners. Implanted by physician; used in clinical setting for pain management. Output is electrical stimulation pulse; affects patient by modulating pain signals. Benefits include chronic pain relief.

Technological Characteristics

Implantable spinal cord stimulation lead. Model 8000 series. Designed for compatibility with external RF receivers, transmitters, and screener cables. Class II device (21 CFR 882.5880).

Indications for Use

Indicated for management of chronic pain of trunk and/or extremities. For prescription use only.

Regulatory Classification

Identification

An implanted spinal cord stimulator for pain relief is a device that is used to stimulate electrically a patient's spinal cord to relieve severe intractable pain. The stimulator consists of an implanted receiver with electrodes that are placed on the patient's spinal cord and an external transmitter for transmitting the stimulating pulses across the patient's skin to the implanted receiver.

Reference Devices

• Medtronic Mattrix Model 3272 RF system
• Medtronic X-TREL Model 3470 RF system
• Medtronic Model 7495 Quadripolar extension
• Medtronic Model 3550-05 Percutaneous Extension
• Medtronic Model 3550-03 Screener cable
• Medtronic Model 3628 DualScreen Screener
• ANS TS-8 Test Stimulator
• ANS MNT90T/TR-16 Test Stimulator

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized graphic of an eagle or bird-like figure with three human profiles embedded within its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the graphic.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 8 2003

Drew Johnson Vice President Regulatory and Clinical Affairs Advanced Neuromodulation Systems, Inc. 6501 Windcrest Drive, Suite 100 Plano, Texas 75024

Re: K030674

Trade/Device Name: Axxess Spinal Cord Stimulation Lead Regulation Number: 21 CFR 882.5880 Regulation Name: Implanted Spinal Cord Stimulator for Pain Relief Regulatory Class: Class II Product Code: GZB Dated: February 21, 2003 Received: March 4, 2003

Dear Mr. Johnson:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set

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Page 2 - Mr. Drew Johnson

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.qov/cdrh/dsma/dsmamain.html

Sincerely yours.

Mark A. Wilkerson

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use Page

510(k) Number (if known):

K030674

Device Name:

## Axxess Spinal Cord Stimulation Lead, Model 8000 Series

Indications for Use: The AXXESS™ Lead is designed to be utilized as the lead component of a spinal cord stimulation system and is used to aid in the management of chronic pain of the trunk and/or extremities.

The AXXESS™ lead system is designed to be used with the following devices:

- Medtronic® Mattrix® Model 3272 RF system receiver and compatible transmitter, or .
- Medtronic® X-TREL® Model 3470 RF system receiver and compatible transmitter ● using the Medtronic® Model 7495 Quadripolar extension , and
- Medtronic® Model 3550-05 Percutaneous Extension with the Medtronic® Model 3550-. 03 Screener cable, and
- The Medtronic® Model 3628 DualScreen™ Screener using Axxess Screener Cable or ●
- The ANS TS-8 or MNT90T/TR-16 Test Stimulator using Axxess Screener Cable. ●

Mark A. Milken

Division Sien-Off) Division of General, Restorative and Neurological Devices

510(k) Number_

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use V (Per 21 CFR 801.109) Or

Over-the-Counter Use -------